Respiratory pressure therapy device

ABSTRACT

Apparatus for generating a supply of air at positive pressure for the amelioration or treatment of a respiratory disorder comprising a housing, a blower structured and configured to produce a flow of air at positive pressure, a flexible connector electrically and physically connected to the blower; and a blower rotation limitation structure configured to reduce rotation of the blower during use. The apparatus may comprise first and second blower suspensions for holding opposite ends of the blower. The blower suspension(s) may be flexible and in tension. The apparatus may comprise one or more connector anchors for anchoring a longitudinal middle section of the flexible connector to another part of the apparatus.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/456,839, filed Mar. 13, 2017, which claims the benefit of U.S.Provisional Application No. 62/307,882, filed Mar. 14, 2016, each ofwhich are incorporated herein by reference in its entirety.

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

BACKGROUND OF THE TECHNOLOGY 2.1 Field of the Technology

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. The present technology also relates to medical devices orapparatus, and their use.

2.2 Description of the Related Art 2.2.1 Human Respiratory System andits Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2011.

A range of respiratory disorders exist. Certain disorders may becharacterised by particular events, e.g. apneas, hypopneas, andhyperpneas.

A range of therapies have been used to treat or ameliorate suchconditions. Furthermore, otherwise healthy individuals may takeadvantage of such therapies to prevent respiratory disorders fromarising. However, these have a number of shortcomings.

2.2.2 Therapy

Continuous Positive Airway Pressure (CPAP) therapy has been used totreat Obstructive Sleep Apnea (OSA). The mechanism of action is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion, such as by pushing the soft palate andtongue forward and away from the posterior oropharyngeal wall. Treatmentof OSA by CPAP therapy may be voluntary, and hence patients may electnot to comply with therapy if they find devices used to provide suchtherapy one or more of: uncomfortable, difficult to use, expensive andaesthetically unappealing.

Non-invasive ventilation (NIV) provides ventilatory support to a patientthrough the upper airways to assist the patient breathing and/ormaintain adequate oxygen levels in the body by doing some or all of thework of breathing. The ventilatory support is provided via anon-invasive patient interface. NIV has been used to treat CSR andrespiratory insufficiency, in forms such as OHS, COPD, MD and Chest Walldisorders. In some forms, the comfort and effectiveness of thesetherapies may be improved.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and may be providedusing a tracheostomy tube. In some forms, the comfort and effectivenessof these therapies may be improved.

2.2.3 Treatment Systems

These therapies may be provided by a treatment system or device. Suchsystems and devices may also be used to diagnose a condition withouttreating it.

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

Another form of treatment system is a mandibular repositioning device.

2.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment toits wearer, for example by providing a flow of air to an entrance to theairways. The flow of air may be provided via a mask to the nose and/ormouth, a tube to the mouth or a tracheostomy tube to the trachea of apatient. Depending upon the therapy to be applied, the patient interfacemay form a seal, e.g., with a region of the patient's face, tofacilitate the delivery of gas at a pressure at sufficient variance withambient pressure to effect therapy, e.g., at a positive pressure ofabout 10 cmH₂O relative to ambient pressure. For other forms of therapy,such as the delivery of oxygen, the patient interface may not include aseal sufficient to facilitate delivery to the airways of a supply of gasat a positive pressure of about 10 cmH₂O.

Certain other mask systems may be functionally unsuitable for thepresent field. For example, purely ornamental masks may be unable tomaintain a suitable pressure. Mask systems used underwater swimming ordiving may be configured to guard against ingress of water from anexternal higher pressure, but not to maintain air internally at a higherpressure than ambient.

Certain masks may be impractical for use while sleeping, e.g. forsleeping while lying on one's side in bed with a head on a pillow.

CPAP therapy is highly effective to treat certain respiratory disorders,provided patients comply with therapy. If a mask is uncomfortable, ordifficult to use a patient may not comply with therapy. Since it isoften recommended that a patient regularly wash their mask, if a mask isdifficult to clean (e.g., difficult to assemble or disassemble),patients may not clean their mask and this may impact on patientcompliance.

For these reasons, patient interfaces for delivery of CPAP during sleepform a distinct field.

2.2.3.1.1 Seal-Forming Portion

Patient interfaces may include a seal-forming portion. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming portion can have a direct impact the effectiveness andcomfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming portion is to engage with the face inuse. In one form of patient interface, a seal-forming portion maycomprise two sub-portions to engage with respective left and rightnares. In one form of patient interface, a seal-forming portion maycomprise a single element that surrounds both nares in use. Such singleelement may be designed to for example overlay an upper lip region and anasal bridge region of a face. In one form of patient interface aseal-forming portion may comprise an element that surrounds a mouthregion in use, e.g. by forming a seal on a lower lip region of a face.In one form of patient interface, a seal-forming portion may comprise asingle element that surrounds both nares and a mouth region in use.These different types of patient interfaces may be known by a variety ofnames by their manufacturer including nasal masks, full-face masks,nasal pillows, nasal puffs and oro-nasal masks.

2.2.3.1.2 Positioning and Stabilising

A seal-forming portion of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming portion, and to maintain it in sealingrelation with the appropriate portion of the face.

2.2.3.2 Vent Technologies

Some forms of respiratory treatment systems may include a vent to allowthe washout of exhaled carbon dioxide. The vent may allow a flow of gasfrom an interior space of the patient interface, e.g., the plenumchamber, to an exterior of the patient interface, e.g., to ambient. Thevent may comprise an orifice and gas may flow through the orifice in useof the mask. Many such vents are noisy. Others may become blocked in useand thus provide insufficient washout. Some vents may be disruptive ofthe sleep of a bed partner 1100 of the patient 1000, e.g. through noiseor focussed airflow.

ResMed Limited has developed a number of improved mask venttechnologies. See International Patent Application Publication No. WO1998/034,665; International Patent Application Publication No. WO2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application PublicationNo. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

Table of noise of prior masks (ISO 17510-2: 2007, 10 cmH₂O pressure at 1m) A-weighted A-weighted sound power sound pressure level dB(A) dB(A)Year Mask name Mask type (uncertainty) (uncertainty) (approx.) Glue-on(*) nasal 50.9 42.9 1981 ResCare nasal 31.5 23.5 1993 standard (*)ResMed nasal 29.5 21.5 1998 Mirage ™ (*) ResMed nasal 36 (3) 28 (3) 2000UltraMirage ™ ResMed nasal 32 (3) 24 (3) 2002 Mirage Activa ™ ResMednasal 30 (3) 22 (3) 2008 Mirage Micro ™ ResMed nasal 29 (3) 22 (3) 2008Mirage ™ SoftGel ResMed nasal 26 (3) 18 (3) 2010 Mirage ™ FX ResMednasal 37   29   2004 Mirage Swift ™ pillows (*) ResMed nasal 28 (3) 20(3) 2005 Mirage Swift ™ pillows II ResMed nasal 25 (3) 17 (3) 2008Mirage Swift ™ pillows LT ResMed AirFit nasal 21 (3) 13 (3) 2014 P10pillows (* one specimen only, measured using test method specified inISO 3744 in CPAP mode at 10 cmH₂O)Sound pressure values of a variety ofobjects are listed below

A-weighted sound pressure Object dB(A) Notes Vacuum cleaner: Nilfisk 68ISO 3744 at 1 m Walter Broadly Litter Hog: B+ distance GradeConversational speech 60 1 m distance Average home 50 Quiet library 40Quiet bedroom at night 30 Background in TV studio 20

2.2.3.3 Respiratory Pressure Therapy (RPT) Device

Air pressure generators are known in a range of applications, e.g.industrial-scale ventilation systems. However, air pressure generatorsfor medical applications have particular requirements not fulfilled bymore generalised air pressure generators, such as the reliability, sizeand weight requirements of medical devices. In addition, even devicesdesigned for medical treatment may suffer from shortcomings, pertainingto one or more of: comfort, noise, ease of use, efficacy, size, weight,manufacturability, cost, and reliability.

An example of the special requirements of certain RPT devices isacoustic noise.

Table of noise output levels of prior RPT devices (one specimen only,measured using test method specified in ISO 3744 in CPAP mode at 10cmH₂O). A-weighted sound power RPT Device name level dB(A) Year(approx.) C-Series Tango ™ 31.9 2007 C-Series Tango ™ 33.1 2007 withHumidifier S8 Escape ™ II 30.5 2005 S8 Escape ™ II 31.1 2005 with H4i ™Humidifier S9 AutoSet ™ 26.5 2010 S9 AutoSet ™ 28.6 2010 with H5iHumidifier

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed Limited. Another exampleof an RPT device is a ventilator. Ventilators such as the ResMedStellar™ Series of Adult and Paediatric Ventilators may provide supportfor invasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD.

The ResMed Elisèe™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit. RPT devicestypically comprise a pressure generator, such as a motor-driven bloweror a compressed gas reservoir, and are configured to supply a flow ofair to the airway of a patient. In some cases, the flow of air may besupplied to the airway of the patient at positive pressure. The outletof the RPT device is connected via an air circuit to a patient interfacesuch as those described above.

The designer of a device may be presented with an infinite number ofchoices to make. Design criteria often conflict, meaning that certaindesign choices are far from routine or inevitable. Furthermore, thecomfort and efficacy of certain aspects may be highly sensitive tosmall, subtle changes in one or more parameters.

2.2.3.4 Humidifier

Delivery of a flow of air without humidification may cause drying ofairways. The use of a humidifier with an RPT device and the patientinterface produces humidified gas that minimizes drying of the nasalmucosa and increases patient airway comfort. In addition in coolerclimates, warm air applied generally to the face area in and about thepatient interface is more comfortable than cold air. A range ofartificial humidification devices and systems are known, however theymay not fulfil the specialised requirements of a medical humidifier.

Medical humidifiers are used to increase humidity and/or temperature ofthe flow of air in relation to ambient air when required, typicallywhere the patient may be asleep or resting (e.g. at a hospital). Amedical humidifier for bedside placement may be small. A medicalhumidifier may be configured to only humidify and/or heat the flow ofair delivered to the patient without humidifying and/or heating thepatient's surroundings. Room-based systems (e.g. a sauna, an airconditioner, or an evaporative cooler), for example, may also humidifyair that is breathed in by the patient, however those systems would alsohumidify and/or heat the entire room, which may cause discomfort to theoccupants. Furthermore medical humidifiers may have more stringentsafety constraints than industrial humidifiers

While a number of medical humidifiers are known, they can suffer fromone or more shortcomings. Some medical humidifiers may provideinadequate humidification, some are difficult or inconvenient to use bypatients.

2.2.3.5 Data Management

There may be clinical reasons to obtain data to determine whether thepatient prescribed with respiratory therapy has been “compliant”, e.g.that the patient has used their RPT device according to certain a“compliance rule”. One example of a compliance rule for CPAP therapy isthat a patient, in order to be deemed compliant, is required to use theRPT device for at least four hours a night for at least 21 of 30consecutive days. In order to determine a patient's compliance, aprovider of the RPT device, such as a health care provider, may manuallyobtain data describing the patient's therapy using the RPT device,calculate the usage over a predetermined time period, and compare withthe compliance rule. Once the health care provider has determined thatthe patient has used their RPT device according to the compliance rule,the health care provider may notify a third party that the patient iscompliant.

There may be other aspects of a patient's therapy that would benefitfrom communication of therapy data to a third party or external system.

Existing processes to communicate and manage such data can be one ormore of costly, time-consuming, and error-prone.

BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the diagnosis, amelioration, treatment, or prevention ofrespiratory disorders having one or more of improved comfort, cost,efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe diagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to methods used in thediagnosis, amelioration, treatment or prevention of a respiratorydisorder.

An aspect of certain forms of the present technology is to providemethods and/or apparatus that improve the compliance of patients withrespiratory therapy.

An aspect of the present technology relates to an RPT device structuredand configured to reduce noise output, e.g., while maintaining arelatively small size.

An aspect of the present technology relates to an RPT device includingan inlet having a plurality of inlet tubes, e.g., arranged in an array,to reduce noise output.

An aspect of the present technology relates to apparatus for generatinga supply of air at positive pressure for the amelioration or treatmentof a respiratory disorder, the apparatus comprising a housing, a blowerpositioned in the housing, the blower being structured and configured toproduce a flow of air at positive pressure, a flexible connectorelectrically and physically connected to the blower, and a blowerrotation limitation structure configured to reduce rotation of theblower during use. The blower rotation limitation structure may comprisea first rotation limitation member provided on the first blowersuspension, the first rotation limitation member interacting in use witha second rotation limitation member provided on the blower to limitrotation of the blower. In one example, the first rotation limitationmember comprises a notch on the blower and the second rotationlimitation member comprises a tongue provided to the first blowersuspension, the notch and tongue being configured to engage with eachother to limit rotation of the blower.

Another aspect of the present technology relates to apparatus forgenerating a supply of air at positive pressure for the amelioration ortreatment of a respiratory disorder, the apparatus comprising a housing,a blower positioned in the housing, the blower being structured andconfigured to produce a flow of air at positive pressure, a first blowersuspension structured and configured to support a first end of theblower adjacent a blower outlet of the blower, a second blowersuspension structured and configured to support a second end of theblower adjacent a blower inlet of the blower, the second end being at anopposite end of the blower to the first end, and a blower rotationlimitation structure configured to reduce rotation of the blower duringuse. In an example, the apparatus comprises a first plate assembly and asecond plate assembly, wherein the first plate assembly comprises thefirst blower suspension and a first base plate and the second blowerassembly comprises the second blower suspension and a second base plate.

Another aspect of the present technology relates to apparatus forgenerating a supply of air at positive pressure for the amelioration ortreatment of a respiratory disorder, the apparatus comprising a housing,a blower positioned in the housing, the blower being structured andconfigured to produce a flow of air at positive pressure, a flexibleconnector electrically and physically connected to the blower, and oneor more connector anchors for anchoring a longitudinal middle section ofthe flexible connector to another part of the apparatus.

Another aspect of the present technology relates to apparatus forgenerating a supply of air at positive pressure for the amelioration ortreatment of a respiratory disorder, the apparatus comprising a housing,a blower positioned in the housing, the blower being structured andconfigured to produce a flow of air at positive pressure, a blowersuspension to support the blower, wherein the blower suspension isflexible and in tension.

An aspect of certain forms of the present technology is a medical devicethat is easy to use, e.g. by a person who does not have medicaltraining, by a person who has limited dexterity or by a person withlimited experience in using this type of medical device.

An aspect of one form of the present technology is a portable RPT devicethat may be carried by a person, e.g., around the home of the person.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Also, various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

4.1 TREATMENT SYSTEMS

FIG. 1A shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal pillows, receiving a supply ofair at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an aircircuit 4170 to the patient 1000. A bed partner 1100 is also shown.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receiving a supply of airat positive pressure from an RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receiving a supply ofair at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an aircircuit 4170 to the patient 1000.

4.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

FIG. 2 shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

4.3 PATIENT INTERFACE

FIG. 3 shows a patient interface in the form of a nasal mask inaccordance with one form of the present technology.

4.4 RPT DEVICE

FIG. 4A is a perspective view of an RPT device in accordance with oneform of the present technology.

FIG. 4B is another perspective view of the RPT device of FIG. 4A.

FIG. 4C is a perspective view of the RPT device of FIG. 4A, with anintermediate cover and portions of the housing removed.

FIG. 4D is another perspective view of the RPT device of FIG. 4A, withan intermediate cover and portions of the housing removed.

FIG. 4E is a top view of the RPT device of FIG. 4A, with an intermediatecover and portions of the housing removed.

FIG. 4F is an exploded view of components of the RPT device shown inFIGS. 4C to 4E.

FIG. 4G is a further exploded view of components of the RPT device shownin FIGS. 4C to 4E.

FIG. 4H is an exploded view of the RPT device shown in FIG. 4A.

FIG. 4I is a cross-sectional view of the RPT device shown in FIG. 4A.

FIG. 4J is an exploded and cross-sectional view of the RPT device shownin FIG. 4A.

FIG. 4K is an enlarged portion of the RPT device of FIG. 4J.

FIG. 4L is an enlarged portion of the RPT device of FIG. 4J.

FIG. 4M is a perspective view of a first plate assembly for an RPTdevice in accordance with one form of the present technology.

FIG. 4N is a cross-sectional view of the first plate assembly shown inFIG. 4M.

FIG. 4O is a perspective view of a second plate assembly for an RPTdevice in accordance with one form of the present technology.

FIG. 4P is another perspective view of the second plate assembly shownin FIG. 4O.

FIG. 4Q is a top view showing the arrangement of first and second plateassemblies for an RPT device in accordance with one form of the presenttechnology.

FIG. 4R is a cross-sectional view through line 4R-4R of FIG. 4Q.

FIG. 4S is a schematic view of an inlet tube array for an RPT device inaccordance with one form of the present technology.

FIG. 4T is a schematic view of an inlet tube array for an RPT device inaccordance with one form of the present technology.

FIG. 4U is a schematic view of an inlet tube array for an RPT device inaccordance with one form of the present technology.

FIG. 4V is a schematic diagram of the algorithms implemented in an RPTdevice in accordance with one form of the present technology.

FIG. 4W1 is a perspective view of an external battery for powering anRPT device in accordance with one form of the present technology.

FIG. 4W2 is another perspective view of the external battery shown inFIG. 4W1.

FIG. 4X1 is a perspective view of the external battery of FIG. 4W1 beingengaged with the RPT device of FIG. 4A in accordance with one form ofthe present technology.

FIG. 4X2 is another perspective view of the external battery and RPTdevice shown in FIG. 4X1.

FIG. 4Y1 is a perspective view of the external battery of FIG. 4W1engaged with the RPT device of FIG. 4A in accordance with one form ofthe present technology.

FIG. 4Y2 is another perspective view of the external battery and RPTdevice shown in FIG. 4Y1.

FIG. 4Z1 is a perspective view of a blower and electrical connector inaccordance with one form of the present technology.

FIG. 4Z2 is a perspective view of part of an RPT device including theblower and electrical connector shown in FIG. 4Z1.

4.5 HUMIDIFIER

FIG. 5A shows an isometric view of a humidifier in accordance with oneform of the present technology.

FIG. 5B shows an isometric view of a humidifier in accordance with oneform of the present technology, showing a humidifier reservoir 5110removed from the humidifier reservoir dock 5130.

FIG. 5C shows a schematic of a humidifier in accordance with one form ofthe present technology.

4.6 BREATHING WAVEFORMS

FIG. 6 shows a model typical breath waveform of a person while sleeping.

DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

The following description is provided in relation to various exampleswhich may share one or more common characteristics and/or features. Itis to be understood that one or more features of any one example may becombinable with one or more features of another example or otherexamples. In addition, any single feature or combination of features inany of the examples may constitute a further example.

5.1 THERAPY

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

In certain examples of the present technology, a supply of air atpositive pressure is provided to the nasal passages of the patient viaone or both nares.

In certain examples of the present technology, mouth breathing islimited, restricted or prevented.

5.2 TREATMENT SYSTEMS

In one form, the present technology comprises an apparatus or device fortreating a respiratory disorder. The apparatus or device may comprise anRPT device 4000 or 8000 for supplying pressurised air to the patient1000 via an air circuit 4170 to a patient interface 3000.

5.3 PATIENT INTERFACE

As shown in FIG. 3, a non-invasive patient interface 3000 in accordancewith one aspect of the present technology comprises the followingfunctional aspects: a seal-forming structure 3100, a plenum chamber3200, a positioning and stabilising structure 3300, a vent 3400, oneform of connection port 3600 for connection to air circuit 4170, and aforehead support 3700. In some forms a functional aspect may be providedby one or more physical components. In some forms, one physicalcomponent may provide one or more functional aspects. In use theseal-forming structure 3100 is arranged to surround an entrance to theairways of the patient so as to facilitate the supply of air at positivepressure to the airways.

5.3.1 Seal-Forming Structure

In one form of the present technology, a seal-forming structure 3100provides a seal-forming surface, and may additionally provide acushioning function.

A seal-forming structure 3100 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In one form the seal-forming portion of the non-invasive patientinterface 3000 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

In one form, the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on a chin-region of thepatient's face.

5.3.2 Plenum Chamber

The plenum chamber 3200 has a perimeter that is shaped to becomplementary to the surface contour of the face of an average person inthe region where a seal will form in use. In use, a marginal edge of theplenum chamber 3200 is positioned in close proximity to an adjacentsurface of the face. Actual contact with the face is provided by theseal-forming structure 3100. The seal-forming structure 3100 may extendin use about the entire perimeter of the plenum chamber 3200.

5.3.3 Positioning and Stabilising Structure

The seal-forming structure 3100 of the patient interface 3000 of thepresent technology may be held in sealing position in use by thepositioning and stabilising structure 3300.

In one form of the present technology, a positioning and stabilisingstructure 3300 is provided that is configured in a manner consistentwith being worn by a patient while sleeping. In one example thepositioning and stabilising structure 3300 has a low profile, orcross-sectional thickness, to reduce the perceived or actual bulk of theapparatus. In one example, the positioning and stabilising structure3300 comprises at least one strap having a rectangular cross-section. Inone example the positioning and stabilising structure 3300 comprises atleast one flat strap.

In one form of the present technology, a positioning and stabilisingstructure 3300 comprises a strap constructed from a laminate of a fabricpatient-contacting layer, a foam inner layer and a fabric outer layer.In one form, the foam is porous to allow moisture, (e.g., sweat), topass through the strap. In one form, the fabric outer layer comprisesloop material to engage with a hook material portion.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap that is extensible, e.g.resiliently extensible. For example the strap may be configured in useto be in tension, and to direct a force to draw a cushion into sealingcontact with a portion of a patient's face. In an example the strap maybe configured as a tie.

In certain forms of the present technology, a positioning andstabilising structure 3300 comprises a strap that is bendable and e.g.non-rigid. An advantage of this aspect is that the strap is morecomfortable for a patient to lie upon while the patient is sleeping.

5.3.4 Vent

In one form, the patient interface 3000 includes a vent 3400 constructedand arranged to allow for the washout of exhaled gases, e.g. carbondioxide.

One form of vent 3400 in accordance with the present technologycomprises a plurality of holes, for example, about 20 to about 80 holes,or about 40 to about 60 holes, or about 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Alternatively,the vent 3400 is located in a decoupling structure, e.g., a swivel.

5.3.5 Decoupling Structure(s)

In one form the patient interface 3000 includes at least one decouplingstructure, for example, a swivel or a ball and socket.

5.3.6 Connection Port

Connection port 3600 allows for connection to the air circuit 4170.

5.3.7 Forehead Support

In one form, the patient interface 3000 includes a forehead support3700.

5.3.8 Anti-Asphyxia Valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

5.3.9 Ports

In one form of the present technology, a patient interface 3000 includesone or more ports that allow access to the volume within the plenumchamber 3200. In one form this allows a clinician to supply supplementaloxygen. In one form, this allows for the direct measurement of aproperty of gases within the plenum chamber 3200, such as the pressure.

5.4 RPT DEVICE

An RPT device in accordance with one aspect of the present technologycomprises mechanical and pneumatic components, electrical components andis configured to execute one or more algorithms.

FIGS. 4A to 4R illustrate an RPT device 8000 according to an example ofthe present technology. As illustrated, the RPT device 8000 includes anexternal housing 8010 including an upper or top housing portion 8012, alower or bottom housing portion 8014, a first end portion 8016 includinga housing inlet 8018 and a housing outlet 8020, and a second end portion8022 providing an end cover including faceplate 8024.

The housing 8010 supports and/or surrounds internal components of theRPT device 8000 including blower 8030, intermediate cover 8040, firstplate assembly 8050, second plate assembly 8060, and a printed circuitboard assembly (PCBA) 8070 including a main printed circuit board (mainPCB) 8072 and a secondary printed circuit board (secondary PCB) 8074.

The housing 8010 and internal components of the RPT device 8000cooperate to form the pneumatic air flow path or pneumatic block thatextends from the housing inlet 8018 to the blower inlet 8032 of theblower 8030 and from the blower outlet 8034 of the blower 8030 to thehousing outlet 8020.

In an example, the housing and the internal components cooperate to forman air flow path having a general U-shape extending from the housinginlet to the housing outlet. For example, the U-shaped air flow path mayinclude an inlet leg extending from the housing inlet, an outlet legextending from the housing outlet, and a connecting leg thatinterconnects the inlet leg and the outlet leg. In an example, the inletleg and the outlet leg are generally parallel to one another. In anexample, the blower is provided along a leg of the U-shape, e.g., alongan outlet leg of the U-shape extending from the housing outlet. In anexample, the blower includes an axis that is generally co-linear with anaxis of the outlet leg of the U-shape. In an example, the U-shaped airflow path extends substantially in the same plane.

The RPT device 8000 is configured and structured to reduce noise outputof the RPT device 8000 while maintaining a relatively small size.

In the illustrated example, the RPT device 8000 provides two chambers,i.e., first chamber 8001 and second chamber 8002. The first chamber 8001is relatively large compared to the second chamber 8002. As illustrated,the blower 8030 is supported in the first chamber 8001, and receives airat the blower inlet 8032 from the second chamber 8002 (i.e., blower andblower inlet thereof located downstream of the chambers). The first andsecond plate assemblies 8050, 8060 define at least a portion of thefirst and second chambers 8001, 8002, and each of the first and secondplate assemblies 8050, 8060 include a blower suspension 8054, 8064 thatsupports the blower 8030 within the first chamber 8001 and separates andseals air flow through the first chamber 8001 from air flow through aninterior of the blower 8030. In addition, each of the first and secondplate assemblies 8050, 8060 include at least one tube (e.g., inlet tubearray 8052 and flow tube array 8062, respectively) such that air entersand exits the first chamber 8001 via at least one tube to reduce noise.

In the illustrated example best shown in FIG. 4E, the air flow path ofthe RPT device 8000 is structured and arranged such that air enters thehousing 8010 via the housing inlet 8018, passes through the inlet tubearray 8052 provided by the first plate assembly 8050, and into the firstchamber 8001. The first chamber 8001 receives air from the inlet tubearray 8052 and delivers the air to the flow tube array 8062 provided tothe second plate assembly 8060. The air passes through the flow tubearray 8062 and into the second chamber 8002. The second chamber 8002receives air from the flow tube array 8062 and delivers the air to theblower inlet 8032 of the blower 8030. The air flows through the blower8030 such that a flow of air at positive pressure is provided at theblower outlet 8034 of the blower 8030, which pressurized air exits thehousing 8010 via the housing outlet 8020. The direction of air flowthrough inlet tube array 8052, first chamber 8001 and flow tube array8062 is generally in a first direction, that direction being parallel tolongitudinal axes of the inlet tubes 8055 and flow tubes 8065. Thedirection of air flow through blower 8030 is generally in a seconddirection, that direction being along the longitudinal axis of theblower 8030. The first and second directions are parallel and offsetfrom each other by a lateral distance. The air flow through RPT device8000 therefore follows a generally U-shaped or ‘squared-U-shaped’ path.This has the advantage of allowing a compact design of the RPT device.

In an example, one or more flow rate sensors may be provided to the RPTdevice 8000 and structured and configured to measure a first pressure inthe first chamber 8001 and a second pressure in the second chamber 8002to determine an air flow rate. The first pressure and the secondpressure may be used to determine a flow rate based on a configurationof the flow tube array 8062, such as a pressure drop and/or theaerodynamic impedance. One flow rate sensor may be provided that is ableto measure both the first and second pressures. Alternatively, two flowrate sensors may be provided: a first flow rate sensor to measure thefirst pressure in the first chamber 8001; and a second flow rate sensorto measure the second pressure in the second chamber 8002.

In an alternative example, one or more pressure sensors may be providedto the RPT device 8000 and may be structured and configured to measure afirst pressure in the first chamber 8001 and a second pressure in thesecond chamber 8002 to determine an air flow rate. The pressure sensorsmay be in communication with a processor that is configured to determinethe flow rate through the RPT device 8000 based on the received firstand second pressure measurements. The processor may be located proximateto or remote from the pressure sensors, for example the pressure sensorsand processor may be in wired or wireless communication.

5.4.1 RPT Device Mechanical & Pneumatic Components

An RPT device may comprise one or more of the following components in anintegral unit. In an alternative form, one or more of the followingcomponents may be located as respective separate units.

5.4.1.1 Housing

As best shown in FIGS. 4H to 4K, the top housing portion 8012 of thehousing 8010 includes a first part or base mold 8012A constructed of arelatively rigid material (e.g., polypropylene) and a second part orovermold 8012B constructed of a relatively soft material (e.g.,thermoplastic elastomer (TPE) or silicone) that is provided (e.g., byovermolding) to the first part 8012A. In the illustrated example, theovermold 8012B is provided to an exterior surface of the base mold8012A, however, it should be appreciated that the overmold 8012B may beprovided to interior and/or exterior surfaces of the base mold 8012A.Softness of the overmold 8012B may provide a desirable tactile qualityto a user of the RPT device 8000. The overmold 8012B may comprise ahighly damped material to improve shock resistance and provide dampingproperties to attenuate wall-radiated noise.

As best shown in FIGS. 4A, 4B, 4H, 4J, and 4K, the top housing portion8012 includes an on/off or power button 8003 and a wireless (e.g.,Bluetooth) connection button 8004, each of which is structured andconfigured to interact with the PCBA 8070. However, it should beappreciate that the RPT device 8000 may include additional and/oralternative input devices to allow a user to interact with the device,e.g., one or more buttons, switches, dials, touch screen.

In the illustrated example, as best shown in FIGS. 4H, 4J, and 4K, thebase mold 8012A provides a cantilevered button portion 8003A of thepower button 8003 with a groove around the side of the button portion8003A that allows the button portion 8003A to flex with respect to thebase mold 8012A. The overmold 8012B provides a button portion 8003Bincluding a raised portion of the power button 8003 and webbing withinthe groove around the side of the button portion 8003A. The raisedportion and webbing of the button portion 8003B provide a soft tactilefeel for ease of use and grip and spring (button return) force.Alternatively, the base mould 8012A may comprise an opening in the placeof cantilevered button portion 8003A through which button portion 8003Bin overmold 8012B can flex. With respect to the wireless (Bluetooth)connection button 8004, the base mold 8012A provides an opening 8004Aand the overmold 8012B provides a button portion 8004B for a softtactile feel for ease of use and grip and spring (button return) force.

The bottom housing portion 8014 of the housing 8010 includes a firstpart or base mold 8014A constructed of a relatively rigid material(e.g., polypropylene) and a second part or overmold 8014B constructed ofa relatively soft material (e.g., TPE or silicone) that is provided(e.g., by overmolding) to the first part 8014A. In the illustratedexample, the overmold 8014B is provided to an exterior surface of thebase mold 8014A, however, it should be appreciated that the overmold8014B may be provided to interior and/or exterior surfaces of the basemold 8014A. Softness of the overmold 8012B may provide a desirabletactile quality to a user of the RPT device 8000. The overmold 8014B maycomprise a highly damped material to improve shock resistance andprovide damping properties to attenuate wall-radiated noise.

As best shown in FIGS. 4F, 4G, and 4L, the bottom housing portion 8014includes interior slots 8015A (e.g., formed by spaced apart side walls)along one end thereof structured and configured to receive and supportthe first plate assembly 8050 and interior slots 8015B (e.g., formed byspaced apart side walls) along an opposing end thereof structured andconfigured to receive and support the second plate assembly 8060. In theembodiment shown in FIGS. 4F, 4G, and 4L, slots 8015A and 8015B areprovided in a plurality of slot sections separated by gaps. In analternative embodiment of the invention, slots 8015A and/or 8015B spanacross the width of bottom housing portion 8014, e.g. additional slotsections are provided which span the gaps between the slot sectionsshown in FIGS. 4F, 4G, and 4L.

Interior blower supports, such as interior ribs 8017, constructed of arelatively soft, high damping material (e.g., TPE or silicone) areprovided (e.g., by overmolding) to the bottom housing portion 8014,e.g., see FIGS. 4F and 4I. The interior ribs 8017 are axially spacedbetween the slots 8015A, 8015B and are structured and configured to atleast partially surround the blower 8030 to provide support, shockresistance and/or damping properties for the blower 8030. One or moreadditional interior blower supports, such as additional ribs may beprovided to the housing at alternative locations, e.g., to provide shockresistance and/or damping properties. It is contemplated that interiorblower supports may be in alternative forms, for example as bumps orplates.

The housing 8010 of the RPT device 8000 may comprise a guiding member tofacilitate alignment and connection of the RPT device 8000 with one ormore complementary components of a respiratory treatment system, such asa humidifier 5000 and/or an external battery 9000 for powering the RPTdevice 8000. For example, the bottom housing portion 8014 includes arail 8019 on each side thereof. In an example, the rails 8019 may alsofacilitate alignment and connection of the top and bottom housingportions 8012, 8014 and/or facilitate handling/grip of the RPT device8000.

Each rail 8019 may define or comprise a movement path for the RPT device8000 in relation to the complementary component, such as in a form of anelongate rectangular indent as shown in FIG. 4H or an elongate,longitudinal protrusion as shown in FIG. 4X1. Other forms of course maybe also suitable.

One or more of the rails 8019 may comprise a retention mechanism (e.g.,a recessed slot 8110 as shown in FIGS. 4X1 and 4X2) for latching the RPTdevice 8000, which may also be used to disengage the RPT device from thecomplementary component connected thereto.

In some forms, each rail 8019 may be configured for relative movementagainst a complementary roller, bearing or a guide. It will beunderstood that alternatively, an RPT device 8000 may comprise a roller,bearing, or a guide for engagement to a rail located on a complementarycomponent.

The top and bottom housing portions 8012, 8014 may be connected to oneanother in any suitable manner, e.g., mechanical fasteners, mechanicalinterlock and/or snap-fit connection.

The first end portion 8016 is supported by the top and bottom housingportions 8012, 8014, e.g., connected to the top and bottom housingportions 8012, 8014 by mechanical fasteners, mechanical interlock and/orsnap-fit connection. The first end portion 8016 is supported adjacentthe first plate assembly 8050 such that the housing inlet 8018 isstructured and configured to communicate with the inlet tube array 8052of the first plate assembly 8050 and the housing outlet 8020 isstructured and configured to communicate with an outlet bellows 8056 ofthe first plate assembly 8050, as described in greater detail below.

The first end portion 8016 includes a cover plate 8021 with a pluralityof openings 8023 that provide the housing inlet 8018. The plurality ofopenings 8023 allow sufficient airflow while preventing the ingress oflarger objects. A recessed opening 8025 (e.g., see FIGS. 4F and 4G) isprovided to the first end portion 8016 in communication with theplurality of openings 8023. The recessed opening 8025 interfaces withthe inlet tube array 8052 provided to the first plate assembly 8050,such that air flows through the plurality of openings 8023 and theopening 8025 to the inlet tube array 8052 in communication with thefirst chamber 8001.

The housing outlet 8020 includes a tube portion 8026 structured andconfigured to receive and retain an end of the air circuit 4170, e.g.,cuff of an air delivery tube. The tube portion 8026 and the end of theair circuit may be connected to one another in any suitable manner,e.g., mechanical interlock, snap-fit connection and/or friction-fit. Theinterior of the tube portion 8026 is structured and configured tocommunicate with the outlet bellows 8056 of the first plate assembly8050, which allows the end of the air circuit 4170 to engage and form aseal with the outlet bellows 8056 which is in communication with theblower outlet 8034 of the blower 8030, thereby forming a seal for theair path. Further examples and details of the connection of the aircircuit to an outlet of an RPT device are disclosed in U.S. ProvisionalAppln. No. 62/130,813, filed Mar. 10, 2015, which is incorporated hereinby reference in its entirety.

The first end portion 8016 also includes an opening or tube portion 8027structured and configured to receive and retain an end of an electricalplug. The tube portion 8027 and the end of the electrical plug may beconnected to one another in any suitable manner, e.g., mechanicalinterlock, snap-fit connection and/or friction-fit. The interior of thetube portion 8027 is structured and configured to communicate with anelectrical socket 8080, which allows the end of the electrical plug toelectrically engage with the electrical socket 8080, thereby allowingelectrical power to be supplied to the RPT device 8000.

The second end portion 8022 is supported by the top and bottom housingportions 8012, 8014, e.g., connected to the top and bottom housingportions 8012, 8014 by mechanical fasteners, mechanical interlock and/orsnap-fit connection. The second end portion 8022 cooperates with aninterior wall 8028 (i.e., provided by the bottom housing portion 8014and the intermediate cover 8040) to define an interior chamber portion8006 (e.g., see FIG. 4I) structured and configured to receive thesecondary PCB 8074. The interior chamber portion 8006 is exterior theair path.

5.4.1.2 Blower

In the illustrated example, the blower 8030 of the RPT device 8000includes a three-stage design structured and configured for producing aflow, or a supply, of air at positive pressure up to 45-50 cmH₂O, e.g.,in the range of 2-50 cmH₂O, e.g., 3-45 cmH₂O, 4-30 cmH₂O. However, inalternative examples, the blower 8030 may include a single stage design,a two stage design, or four or more stage designs.

As best shown in FIG. 4I, the blower 8030 includes a housing 8031including an axial air inlet (blower inlet) 8032 and axial air outlet(blower outlet) 8034 between which are located three stages with threecorresponding impellers 8033A, 8033B, 8033C, i.e., first and secondimpellers 8033A, 8033B positioned on one side of the motor 8035 and athird impeller 8033C positioned on the other side of the motor 8035.However, other suitable impeller arrangements are possible. Eachimpeller is followed by a set of stator vanes structured and configuredto direct the air flow to the next stage.

In the illustrated example, the blower 8030 is supported within thefirst chamber 8001 and the blower housing 8031 is relatively rigid andstructured and configured to sealingly separate air flow through aninterior of the blower 8030 from the first chamber 8001. In an example,the housing 8031 may comprise a plurality of housing portions (e.g.,first housing part including inlet 8032, second housing part includingoutlet 8034, and intermediate housing parts (e.g., stationary componentsproviding stator vanes to direct air flow) that are connected to oneanother (e.g., welded) to a form a substantially sealed structure.

Further examples and details of the blower 8030 are described in PCTPatent Application Publication No. WO 2013/020167, which is incorporatedherein by reference in its entirety.

As described in greater detail below, the first plate assembly 8050 andthe second plate assembly 8060 each include a blower suspension 8054,8064 that cooperate to support the blower 8030 within the housing 8010,provide seals for the air path, isolate vibrations of the blower, andprovide shock resistance. The blower suspension 8054, 8064 may provideadditional spring and damping to isolate vibrations and provide shockresistance. For example, blower suspension 8054, 8064 may be formed froma flexible material such as an elastomer. Specifically, the first plateassembly 8050 provides an outlet end suspension 8054 to support theblower 8030 adjacent the blower outlet 8034 and the second plateassembly 8060 provides an inlet end suspension 8064 to support theblower 8030 adjacent the blower inlet 8032, i.e., a suspension islocated at each end of the blower 8030.

The blower 8030 may be mounted within housing 8010 so that the blowersuspension 8054, 8064 is in a neutral state or, alternatively the blower8030 may be mounted so that the blower suspension 8054, 8064 is intension. For example, slots 8015A and 8015B in bottom housing portion8014 may be located so that the slots are further apart than thedistance between first plate assembly 8050 and second plate assembly8060 when the blower suspension 8054, 8064 is in its neutral state andthe plate assemblies 8050 and 8060 are not mounted in slots 8015A and8015B, for example the RPT device 8000 is in an unassembled state. Inassembling blower 8000 in this way, the first and second plateassemblies 8050 and 8060 are pulled apart in order to insert the firstand second plate assemblies 8050, 8060 into the respective slots 8015A,8015B in the bottom housing portion 8014, which stretches blowersuspension 8054, 8064. This may assist in isolating vibrations in theblower 8030, for example by reducing sag in the blower suspension 8054,8064 and reducing the possibility of the blower 8030 contacting theinternal surfaces of the interior ribs 8017 during use.

5.4.1.3 Intermediate Cover

The intermediate cover 8040 (also referred to as an intermediate housingportion of the housing) is supported between the top and bottom housingportions 8012, 8014 of the housing 8010. The intermediate cover 8040 isstructured and configured to define at least a portion of the air path(e.g., define top and sides of the air path) and to define at least aportion of interior chamber portions exterior of the air path to receivethe PCBA 8070.

Similar to the bottom housing portion 8014 described above, theintermediate cover 8040 includes interior slots 8042A (e.g., formed byspaced apart side walls) along one end thereof structured and configuredto receive and support the first plate assembly 8050 and interior slots8042B (e.g., formed by spaced apart side walls) along an opposing endthereof structured and configured to receive and support the secondplate assembly 8060, e.g., see FIGS. 4H and 4L. Accordingly, theintermediate cover 8040 cooperates with the bottom housing portion 8014to support and retain the first and second plate assemblies 8050, 8060within the RPT device 8000.

In the illustrated example, the intermediate cover 8040 may constitutean upper portion and the bottom housing portion 8014 may constitute alower portion, the upper and lower portions being engageable orseparable in a generally normal direction with respect an axis of theinlet tubes 8055/flow tubes 8065 of each of the first and second plateassemblies 8050, 8060 and/or in a direction generally in plane orparallel with respect to the base plate 8051, 8061. In an example, theupper and lower portions are engageable or separable in a generallynormal direction with respect an axis of at least one tube of the firstplate assembly 8050.

The intermediate cover 8040 also includes an end wall 8028A thatcooperates with an end wall 8028B of the bottom housing portion 8014 todefine interior wall 8028, e.g., see FIGS. 4I and 4L. Interior wall 8028separates the air flow path from the interior chamber portion 8006configured to receive the secondary PCB 8074, e.g., see FIG. 4I. Also,the main wall 8044 of the intermediate cover 8040 cooperates with thetop housing portion 8012 to define an interior chamber portion 8007 toreceive the main PCB 8072, e.g., see FIG. 4I. Accordingly, theintermediate cover 8040 defines interior chamber portions 8006, 8007exterior of the air path to receive the main and secondary PCBs 8072,8074.

The intermediate cover 8040, along with the bottom housing portion 8014and the first and second plate assemblies 8050, 8060, cooperate todefine the top, bottom, and sides of the first and second chambers 8001,8002, and therefore the pneumatic air path that extends to the blowerinlet 8032 of the blower 8030.

In the illustrated example, the intermediate cover 8040 includes a firstpart or base mold 8040A constructed of a relatively rigid material(e.g., polypropylene) and a second part or overmold 8040B constructed ofa relatively soft material (e.g., TPE or silicone) that is provided(e.g., by overmolding) to the first part 8040A. In the illustratedexample, the overmold 8040B is provided to an interior surface of thebase mold 8040A, i.e., overmold 8040B provided along the air flow path.The overmold 8040B provides damping properties to attenuatewall-radiated noise. However, it should be appreciated that the overmold8040B may be provided to interior and/or exterior surfaces of the basemold 8040A.

Also, the overmold 8040B extends along the edges of the intermediatecover 8040, which cooperates with sealing (e.g., TPE or silicone)provided along side wall edges of the bottom housing portion 8014, toseal the air path.

5.4.1.4 First Plate Assembly

As best shown in FIGS. 4M, 4N, and 4I, the first plate assembly 8050includes a base plate 8051, an inlet tube array 8052, and a tube portion8053 including a blower suspension (outlet end suspension) 8054 alongone end and an outlet bellows 8056 along the opposite end. The tubeportion 8053 includes an opening 8053A (e.g., see FIG. 4N) communicatedwith a pressure port 8058. In addition, a sealing lip or sealing flange8059 is provided along the edge or perimeter of the base plate 8051.

In an example, the base plate 8051, the inlet tube array 8052, and thetube portion 8053 comprise a first part or base mold constructed of arelatively rigid material (e.g., polypropylene), and the blowersuspension 8054, outlet bellows 8056, pressure port 8058, and sealinglip 8059 comprise a second part or overmold constructed of a relativelysoft material (e.g., TPE or silicone) that is provided (e.g., byovermolding) to the first part.

As described above, the first plate assembly 8050 is supported betweenthe intermediate cover 8040 and the bottom housing portion 8014, i.e.,base plate 8051 supported within interior slots 8042A, 8015A provided bythe intermediate cover 8040 and the bottom housing portion 8014. Thebase plate 8051 defines a wall of the first chamber 8001 and the sealinglip 8059 along the perimeter of the base plate 8051 provides a sealalong the edge of the first chamber 8001.

The blower suspension 8054 of the first plate assembly 8050 is in theform of an outlet end suspension to support the blower 8030 adjacent theblower outlet 8034 of the blower 8030. The outlet end suspension 8054(e.g., constructed of an elastomeric material such as TPE or silicone)includes a first end portion 8054A provided (e.g., overmolded) to thetube portion 8053, a second end portion 8054B engaged or otherwisesecured to the blower outlet 8034 of the blower 8030, and a radiallyoutwardly extending gusset portion 8054C between the first and secondend portions 8054A, 8054B.

The second end portion 8054B may be secured to the blower 8030 in anysuitable manner, e.g., wrap around an outlet flange provided to bloweroutlet 8034 as shown in FIG. 4I. The blower suspension 8054 seals theblower outlet 8034 to the tube portion 8053, thereby sealing the airpath for air exiting the blower outlet 8034 from the first chamber 8001.Also, the gusset portion 8054C of the blower suspension 8054 allowsflexibility and relative movement to isolate vibrations of the blower8030 and provide shock resistance.

As described above, the outlet bellows 8056 of the first plate assembly8050 is provided within the tube portion 8026 of the housing outlet8020, and is structured and configured to form a seal with an end of theair circuit 4170, e.g., cuff of an air delivery tube. The outlet bellows8056 (e.g., constructed of an elastomeric material such as TPE orsilicone) includes an end portion 8056A provided (e.g., overmolded) tothe tube portion 8053 and a bellows portion 8056B that curves radiallyinwardly from the end portion 8056A. The bellows portion 8056B isflexible to allow the end of the air circuit to engage and form a sealwith the bellows portion 8056B. As shown in FIG. 4M, the perimeter ofthe outlet bellows 8056B may be provided with spaced part projections8056C, e.g., to add rigidity to the base of the outlet bellows 8056B.

The pressure port 8058, which may be integral with the blower suspension8054, is structured and configured to interface or otherwise connect toa pressure sensor.

The inlet tube array 8052 includes a plurality of inlet tubes 8055structured and configured to extend from the base plate 8051 into thefirst chamber 8001, e.g., inlet tubes 8055 extend generallyperpendicular with respect to the base plate 8051. In the illustratedexample, the inlet tube array 8052 provides a first end portion 8052Athat slightly protrudes from one side of the base plate 8051 so as tointerface with the recessed opening 8025 in the first end portion 8016of the housing 8010. As illustrated, the recessed opening 8025 includesshape that corresponds to a shape of the first end portion 8052A alongits outer perimeter. The second end portion 8052B of the inlet tubearray 8052 protrudes from the other side of the base plate 8051 so as toextend into the first chamber 8001. Thus, the air flow path extends fromthe housing inlet 8018, through the inlet tube array 8052, and into thefirst chamber 8001.

This arrangement reduces noise output of the RPT device 8000 byincreasing acoustic impedance through the inlet tubes 8055 whilemaintaining a high inertance. In an example, longer inlet tubes 8055 maybe preferable for noise reduction (due to the higher inertance), and thelength of the inlet tubes 8055 may be tuned or selected to match thespecific noise frequency characteristics of the RPT device 8000.

In an example, the length of inlet tubes 8055 may be configured suchthat it does not adversely interact with any high-amplitude noisefrequencies. For example, the length of inlet tubes 8055 may be tunedsuch that it does not coincide with ¼ or ½ wavelengths of any peaks inthe blower's noise spectrum. Peaks in the blower's noise spectrum (i.e.,tonal peaks) may be caused by one or more of bearing defects, bladepass, turbulence, and structural resonance.

In the illustrated example, each of the plurality of inlet tubes 8055includes a non-circular cross-sectional shape (e.g., hexagonalcross-sectional shape), and the plurality of inlet tubes 8055 arearranged adjacent to one another to form the inlet tube array 8052. Thatis, the inlet tubes 8055 are arranged adjacent to one another such thatadjacent tubes share at least one side wall or side wall portion, i.e.,adjacent tubes include at least one common side wall or side wallportion. As illustrated, adjacent tubes 8055 are separated by a thinwall to allow efficient packaging of the inlet tube array 8052. The useof a plurality of relatively small inlet tubes 8055 may also furtherencourage the flow travelling therethrough to be laminar.

In an example, each of the plurality of inlet tubes 8055 may comprise adraft angle to allow a mould tool to be extracted from the tubes duringthe moulding process. Such draft angle may be in either direction, i.e.,converging away from the base plate 8051 or towards the base plate 8051.

In an example, each of the plurality of inlet tubes 8055 includes alength of about 35-55 mm (e.g., about 40-50 mm, e.g., about 43 mm), awall thickness of about 1 mm, and a flat-to-flat distance (diameter) ofabout 3-5 mm (e.g., about 3.5-4.5 mm, e.g., about 4.33 mm). Thus thecross-sectional area of each hexagonal tube 8055 may be about 10-20 mm²(e.g., about 16.2 mm²), and the total cross-sectional area of all inlettubes 8055 may be about 100-130 mm² (e.g., about 110-120 mm², e.g.,about 114 mm²). However, it should be appreciated that other suitablelengths, wall thicknesses, flat-to-flat distances (diameters), andcross-sectional areas of the tubes 8055 are possible, e.g., depending onthe desired noise characteristic.

In the illustrated example, the inlet tube array 8052 includes seveninlet tubes 8055 arranged with six inlet tubes about a central inlettube. However, it should be appreciated that other suitable number oftubes 8055 are possible (e.g., one or more inlet tubes, e.g., 5-10 inlettubes) and the tubes 8055 may be arranged in other suitable manners(e.g., spaced apart, aligned in columns, etc.)

Each of the plurality of inlet tubes 8055 may be constructed as a singlepart, or may comprise multiple parts. For example, each inlet tube 8055may comprise an outer tube and an inlet restrictor configured to changea diameter of the tube.

The plurality of inlet tubes 8055 may comprise inlet tubes of equallengths and/or unequal lengths. The plurality of inlet tubes 8055 maycomprise a sloped shape at one or more ends.

Also, each of the plurality of inlet tubes 8055 may include othercross-sectional shapes, e.g., circular shape or noncircular shape (e.g.,square, rectangle). In the illustrated example, the inlet tube array8052 includes an outer perimeter with a non-circular shape. However, theouter perimeter shape of the inlet tube array 8052 may include othersuitable shapes, e.g., circular shape or noncircular shape.

For example, FIGS. 4S to 4U illustrate alternative arrangements for theinlet tube array 8052. In FIG. 4S, the inlet tube array 52A includes acircular outer perimeter with each inlet tube including a square ortruncated-square shape. In FIG. 4T, the inlet tube array 52B includes acircular outer perimeter with each inlet tube including a hexagon ortruncated-hexagon shape. In FIG. 4U, the inlet tube array 52C includes asquare outer perimeter with each inlet tube including a square shape.

5.4.1.5 Second Plate Assembly

As best shown in FIGS. 4O and 4P, the second plate assembly 8060includes a base plate 8061, a flow tube array 8062, and a blowersuspension (outlet end suspension) 8064 supported within an opening 8063provided to the base plate 8061. In addition, a sealing lip or sealingflange 8069 is provided along the edge or perimeter of the base plate8061.

In an example, the base plate 8061 and the flow tube array 8062 comprisea first part or base mold constructed of a relatively rigid material(e.g., polypropylene), and the blower suspension 8064 and sealing lip8069 comprise a second part or overmold constructed of a relatively softmaterial (e.g., TPE or silicone) that is provided (e.g., by overmolding)to the first part.

As described above, the second plate assembly 8060 is supported betweenthe intermediate cover 8040 and the bottom housing portion 8014, i.e.,base plate 8061 supported within interior slots 8042B, 8015B provided bythe intermediate cover 8040 and the bottom housing portion 8014. Thebase plate 8061 defines a wall of the first chamber 8001 and the secondchamber 8002, and the sealing lip 8069 along the perimeter of the baseplate 8061 provides a seal along the edge of the first and secondchambers 8001, 8002.

The blower suspension 8064 of the second plate assembly 8060 is in theform of an inlet end suspension to support the blower 8030 adjacent theblower inlet 8032 of the blower 8030. The inlet end suspension 8064(e.g., constructed of an elastomeric material such as TPE or silicone)includes a radially outer portion 8064A provided (e.g., overmolded) tothe opening 8063 of the base plate 8061, a radially inner portion 8064Bengaged or otherwise secured to the blower inlet 8032 of the blower8030, and an intermediate portion 8064C between the outer and innerportions 8064A, 8064B.

The radially inner portion 8064B may be secured to the blower 8030 inany suitable manner, e.g., wrap around an inlet flange provided to theblower inlet 8032 as shown in FIG. 4I. The blower suspension 8064provides a seal along the blower inlet 8032, thereby sealing the blowerinlet 8032 from the first chamber 8001 and providing an air path for airentering the blower inlet 8032 from the second chamber 8002. Also, inthe illustrated example, the intermediate portion 8064C of the blowersuspension 8064 is axially offset from the outer and inner portions8064A, 8064B, which allows flexibility and relative movement to isolatevibrations of the blower 8030 and provide shock resistance.

The flow tube array 8062 includes a plurality of flow tubes 8065structured and configured to extend from the base plate 8061 into thefirst chamber 8001, e.g., flow tubes 8065 extend generally perpendicularwith respect to the base plate 8061. In the illustrated example, eachflow tube 8065 includes a first end portion 8065A provided to the baseplate 8061 and a second end portion 8065B that protrudes from the baseplate 8061 so as to extend into the first chamber 8001. Thus, the airflow path extends from first chamber 8001, through the flow tube array8062, and into the second chamber 8002.

Similar to the inlet tube array 8052, the flow tube array 8062 isconfigured and arranged to reduce noise output of the RPT device 8000 byincreasing acoustic impedance through the flow tubes 8065 whilemaintaining a high inertance.

In the illustrated example, the flow tube array 8062 includes six,spaced-apart flow tubes 8065 generally arranged in three columns of twotubes with the columns generally offset from one another. However, itshould be appreciated that other suitable number of tubes 8065 arepossible (e.g., one or more flow tubes, e.g., 4-10 flow tubes) and thetubes 8065 may be arranged in other suitable manners (e.g., aligned inrows and/or columns, circular arrangement, adjacent tubes engaged withone another, etc.).

In the illustrated example, each of the plurality of flow tubes 8065includes a circular cross-sectional shape, however it should beappreciated that each of the tubes 8065 may include othercross-sectional shapes, e.g., circular shape or noncircular shape.

In an example, each of the plurality of flow tubes 8065 may include anysuitable length, diameter, wall thickness, and cross-sectional area,e.g., depending on the desired noise characteristic. In an example, thelength of the flow tubes 8065 may be tuned or selected to match thespecific noise frequency characteristics of the RPT device 8000.

In an example, each of the plurality of flow tubes 8065 may comprise adraft angle to allow a mould tool to be extracted from the tubes duringthe moulding process. Such draft angle may be in either direction, i.e.,converging away from the base plate 8061 or towards the base plate 8061.

The plurality of flow tubes 8065 may comprise flow tubes of equallengths and/or unequal lengths. The plurality of flow tubes 8065 maycomprise a sloped shape at one or more ends.

5.4.1.6 Arrangement of Inlet Tube Array and Flow Tube Array

In the illustrated example, the inlet tube array 8052 and the flow tubearray 8062 are structured and arranged with respect to one anotherwithin the first chamber 8001 to reduce noise output of the RPT device8000.

As best shown in FIGS. 4Q and 4R, the inlet tube array 8052 is axiallyspaced from the flow tube array 8062, and the tubes 8055 of the inlettube array 8052 include axes that are arranged substantially parallel toaxes of the tubes 8065 of the flow tube array 8062, however the tubes8055 of the inlet tube array 8052 are not arranged co-axially with thetubes 8065 of the flow tube array 8062. This arrangement reduces anamount of noise that is radiated through the flow tube array 8062 andthen directly to the inlet tube array 8052.

The axially offset arrangement may be provided by off-setting a centralaxis of the inlet tube array 8052 (i.e., center axis defined bycombination of all inlet tubes 8055) from a central axis of the flowtube array 8062 (i.e., center axis defined by combination of all flowtubes 8065) and/or the axially offset arrangement may be provided byarranging the inlet tube array 8052 and the flow tube array 8062 suchthat one or more of the individual tubes 8055, 8065 are not co-axial oraxially aligned (i.e., axially offset) with one another. For example,FIG. 4R shows an arrangement wherein each of tubes 8055 of the inlettube array 8052 includes an axis that is axially offset from axis ofeach of the tubes 8065 of the flow tube array 8062 (i.e. none of thetubes 8055 is co-axial with any of the tubes 8065).

In an in-line configuration as illustrated, the tubes 8055 of the inlettube array 8052 may be axially spaced from the tubes 8065 of the flowtube array 8062, e.g., the spacing d (see FIG. 4Q) between the inlettube array 8052 and the flow tube array 8062 may be at least 5 mm, e.g.,between about 10-15 mm.

Also, in the illustrated example, the tubes 8055 of the inlet tube array8052 and the tubes 8065 of the flow tube array 8062 each includes axesthat are aligned substantially parallel with an axis of the blower 8030.

5.4.1.7 Printed Circuit Board Assembly

As described above, the PCBA 8070 includes a main PCB 8072 and asecondary PCB 8074, the main PCB 8072 supported within interior chamberportion 8007 (e.g., defined by the top housing portion 8012 and theintermediate cover 8040), and the secondary PCB 8074 supported withininterior chamber portion 8006 (e.g., defined by the second end portion8022, the intermediate cover 8040, and the bottom housing portion 8014).This arrangement positions the main PCB 8072 and the secondary PCB 8074exterior of the air flow path.

The PCBA 8070 is electrically connected to the blower 8030 by one ormore electrical connectors, e.g., electrical connector 8090 shown inFIGS. 4H and 4L. In the example shown in FIG. 4G, the blower 8030includes an electrical connector portion 8038 extending exterior theblower housing 8031, and the electrical connector 8090 is structured andarranged to electrically connect the electrical connector portion 8038of the blower 8030 to the PCBA 8070.

In an example, the electrical connector 8090 may be a flexible circuitboard (FCB), flexible printed circuits (FPC) and/or flexible flat cables(FFC) to electrically connect the blower 8030 to the PCBA 8070.

In an example, the electrical connector 8090 may be arranged to passthrough an internal air chamber (e.g., through the first chamber 8001)of the RPT device 8000, while not being positioned directly in the airflow path, e.g., such as between the inlet tube array 8052 and the flowtube array 8062. For example, in the illustrated example, the electricalconnector 8090 may be arranged to pass around a periphery of the inlettube array 8052.

The electrical connector 8090 may be pre-formed to a particular shape toreduce potential interference with one or more components of the RPTdevice 8000. Also, the electrical connector 8090 may be sufficientlylong such that the electrical connector 8090 remains slack whenconnected, e.g., to isolate vibration from being transmitted from theblower 8030 through the electrical connector 8090.

In an example, the electrical connector 8090 may be structured andconfigured to help achieve a reliable seal due to its low-profile formfactor. In an example, tape and/or adhesives may be used to further sealany gaps where the electrical connector 8090 exits housing portionsand/or intermediate cover.

5.4.1.8 Blower Rotation Limitation

In one form of the present technology, the RPT device 8000 comprises ablower rotation limitation structure configured to minimise or at leastreduce rotation of the blower 8030 during use. It will be appreciatedthat parts of the blower which rotate during normal use of the blower,for example the impellers 8033A, 8033B, 8033C, are not limited fromrotating. Rotation of the blower 8030 may cause electrical connectionsto/from the blower to be stressed, which may result in disconnection ofthe electrical connections. For example, if blower 8030 shown in FIG. 4Hrotates on its longitudinal axis, electrical connector 8090 will bepulled tight as it is physically connected to the housing 8031 of blower8030, and may rip or be disconnected from PCBA 8070.

The form of the technology shown in FIGS. 4Z1 and 4Z2 addresses thisproblem. As best shown in FIG. 4Z1, blower 8030 comprises a collar 8036provided around inlet 8032. Collar 8036 comprises one or more notches8037 around its circumference. Notch 8037 may be any break, gap orrecess in collar 8036. As best shown in FIG. 4Z2, second plate assembly8060 comprises a structure configured to engage with notch 8037 toreduce rotation of the blower 8030. For example, inlet end suspension8064 may comprise a tongue 8066 that protrudes radially inwardly from aninner edge of the circular aperture in inlet end suspension 8064 thataligns with inlet 8032 in the assembled RPT device 8000. Tongue 8066 isconfigured to engage with notch 8037 in collar 8036 in the assembleddevice and prevent or reduce rotation of the blower 8030 with respect toother parts of RPT device 8000. Notch 8037 is positioned at anorientation around collar 8036 so that the electrical connector 8090 isnot under stress, for example by being stretched tightly, when RPTdevice 8000 is assembled. Notch 8037 may also be positioned to avoidelectrical connector 8090 being overly slack when RPT device 8000 isassembled as this may lead to the electrical connector 8090 beingtangled with other parts of the RPT device 8000 during use. It will beappreciated that the position of tongue 8066 and notch 8037 may differfrom the position in which they are shown in FIGS. 4Z1 and 4Z2.

Other rotation limitation structures may be provided in other forms ofthe technology, for example other structures in which a first rotationlimitation member provided on the blower suspension interacts with asecond rotation limitation member provided on the blower. In oneexample, a tongue may be provided on collar 8036 that engages with anotch provided in inlet end suspension 8064. In another example, a notchor tongue structure may be provided at the outlet end of the blower thatis configured to engage with a complementary notch or tongue structurein the first plate assembly 8050 in addition to or instead of thenotch-and-tongue structure that is provided at the inlet end, such ashas been described above. In other forms of the technology, otherinteracting structures between a part of the blower 8030 and one or bothof first plate assembly 8050 and second plate assembly 8060 may beprovided including, but not limited to, interlocks, clips and adheringparts.

In some forms of the technology, the RPT device 8000 may be structuredand arranged so that the electrical connection between the blower 8030and the PCBA 8070 is unlikely to be disconnected even if the blower 8030does rotate. In one exemplary form of the technology, the electricalconnector 8090 between the blower 8030 and the PCBA 8070, for example alongitudinal middle section of the electrical connector 8090, engageswith another part of the RPT device 8000 in order to isolate two partsof the electrical connector 8090 from movement of the other part.

One example of such a structure is illustrated in FIGS. 4Z1 and 4Z2. Inthis example, electrical connector 8090 comprises one or more tabs 8092located in a longitudinal middle section of the electrical connector8090 (e.g. not at the ends of the electrical connector 8090), the tabs8092 extending outwards from the electrical connector 8090 in adirection perpendicular to the direction in which conducting pathsextend along the length of the electrical connector 8090. Tabs 8092 maybe integral to the electrical connector 8090 and formed, for example,from a thin polymer film to which the conducting paths of the electricalconnector are attached. Tabs 8092 may have one or more holes providedtherein. Alternatively, the tabs may be in the form of hooks or otherstructures able to substantially fixedly engage the electrical connector8090 to another part of the RPT device 8000. Alternatively still, thetabs or any other part of the electrical connector 8090 could befastened to another part of the RPT device 8000 using another mechanism,for example adhesive.

As shown in FIG. 4Z2, the bottom housing portion 8014 comprises one ormore connector anchors 8011 for anchoring the longitudinal middlesection of the electrical connector 8090 to another part of the RPTdevice. Connector anchors 8011 may take the form of posts integrallyformed as part of the bottom housing portion 8014 or the posts may beattached to a main body of the bottom housing portion 8014. The postsare sized and configured so that the posts can be inserted through theholes in tabs 8092 of the electrical connector. In the assembled RPTdevice 8000, the posts act to isolate the parts of electrical connector8090 on either side of tabs 8092 from each other. That is, rotation ofblower 8030 during use may result in a pulling force being transmittedthrough electrical connector 8090 onto tabs 8092 but, since this forceis transmitted to posts, rotation of the blower will not causeelectrical connector 8090 to be pulled out of connection with PCBA 8070.Similarly, vibrations of the blower 8030 transmitted through electricalconnector 8090 are impeded by connector anchors 8011 and may help toreduce vibrations in other parts of the RPT device 8000.

5.4.1.9 Air Filter(s)

An RPT device in accordance with one form of the present technology mayinclude an air filter, or a plurality of air filters.

In one form, an inlet air filter is located at the beginning of thepneumatic path upstream of the blower, such as housed in the cover plate8021.

In one form, an outlet air filter, for example an antibacterial filter,is located between an outlet of the pneumatic block and a patientinterface 3000.

5.4.1.10 Transducer(s)

Transducers may be internal of the RPT device, or external of the RPTdevice. External transducers may be located for example on or form partof the air circuit, e.g., the patient interface. External transducersmay be in the form of non-contact sensors such as a Doppler radarmovement sensor that transmit or transfer data to the RPT device.

In one form of the present technology, one or more transducers may belocated upstream and/or downstream of the blower. The one or moretransducers may be constructed and arranged to measure properties suchas a flow rate, a pressure or a temperature at that point in thepneumatic path.

In one form of the present technology, one or more transducers may belocated proximate to the patient interface 3000.

In one form, a signal from a transducer may be filtered, such as bylow-pass, high-pass or band-pass filtering.

5.4.1.10.1 Flow Rate Sensor

A flow rate sensor in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION.

In one form, a signal representing a flow rate such as a total flow rateQt from the flow rate sensor may be received by a central controller.

5.4.1.10.2 Pressure Sensor

A pressure sensor in accordance with the present technology may belocated in fluid communication with the pneumatic path. An example of asuitable pressure transducer is a sensor from the HONEYWELL ASDX series.An alternative suitable pressure transducer is a sensor from the NPASeries from GENERAL ELECTRIC.

In one form, a signal from the pressure sensor may be received by thecentral controller.

5.4.1.10.3 Motor Speed Transducer

In one form of the present technology a motor speed transducer may beused to determine a rotational velocity of the motor and/or the blower.A motor speed signal from the motor speed transducer may be provided toa therapy device controller. The motor speed transducer may, forexample, be a speed sensor, such as a Hall effect sensor.

5.4.1.11 Anti-Spill Back Valve

In one form of the present technology, an anti-spill back valve may belocated between the humidifier 5000 and the pneumatic block. Theanti-spill back valve is constructed and arranged to reduce the riskthat water will flow upstream from the humidifier 5000, for example tothe motor of the blower.

5.4.1.12 Air Circuit

An air circuit 4170 in accordance with an aspect of the presenttechnology is a conduit or a tube constructed and arranged in use toallow a flow of air to travel between two components such as thepneumatic block and the patient interface 3000.

In particular, the air circuit 4170 may be in fluid connection with theoutlet of the pneumatic block and the patient interface. The air circuitmay be referred to as an air delivery tube. In some cases there may beseparate limbs of the circuit for inhalation and exhalation. In othercases a single limb is used.

In some forms, the air circuit 4170 may comprise one or more heatingelements configured to heat air in the air circuit, for example tomaintain or raise the temperature of the air. The heating element may bein a form of a heated wire circuit, and may comprise one or moretransducers, such as temperature sensors. In one form, the heated wirecircuit may be helically wound around the axis of the air circuit 4170.The heating element may be in communication with a controller such as acentral controller. One example of an air circuit 4170 comprising aheated wire circuit is described in United States Patent Application No.US/2011/0023874, which is incorporated herewithin in its entirety byreference.

5.4.1.13 Oxygen Delivery

In one form of the present technology, supplemental oxygen may bedelivered to one or more points in the pneumatic path, such as upstreamof the pneumatic block, to the air circuit 4170 and/or to the patientinterface 3000.

5.4.2 RPT Device Electrical Components 5.4.2.1 Power Supply

A power supply may be located internal or external of the externalhousing of the RPT device 8000.

In one form of the present technology, power supply provides electricalpower to the RPT device 8000 only. In another form of the presenttechnology, power supply provides electrical power to both RPT device8000 and humidifier 5000.

5.4.2.2 Input Devices

In one form of the present technology, an RPT device 8000 includes oneor more input devices in the form of buttons, switches or dials to allowa person to interact with the device, e.g., buttons 8003, 8004. Thebuttons, switches or dials may be physical devices, or software devicesaccessible via a touch screen. The buttons, switches or dials may, inone form, be physically connected to the external housing, or may, inanother form, be in wireless communication with a receiver that is inelectrical connection to the central controller.

In one form, the input device may be constructed and arranged to allow aperson to select a value and/or a menu option.

5.4.2.3 Central Controller

In one form of the present technology, the central controller is one ora plurality of processors suitable to control an RPT device 8000, e.g.,PCBA 8070 including main PCB 8072 and secondary PCB 8074.

Suitable processors may include an x86 INTEL processor, a processorbased on ARM® Cortex®-M processor from ARM Holdings such as an STM32series microcontroller from ST MICROELECTRONIC. In certain alternativeforms of the present technology, a 32-bit RISC CPU, such as an STR9series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPUsuch as a processor from the MSP430 family of microcontrollers,manufactured by TEXAS INSTRUMENTS may also be suitable.

In one form of the present technology, the central controller is adedicated electronic circuit.

In one form, the central controller is an application-specificintegrated circuit. In another form, the central controller comprisesdiscrete electronic components.

The central controller may be configured to receive input signal(s) fromone or more transducers, one or more input devices, and the humidifier5000.

The central controller may be configured to provide output signal(s) toone or more of an output device, a therapy device controller, a datacommunication interface, and the humidifier 5000.

In some forms of the present technology, the central controller isconfigured to implement the one or more methodologies described herein,such as the one or more algorithms expressed as computer programs storedin a non-transitory computer readable storage medium, such as memory. Insome forms of the present technology, the central controller may beintegrated with an RPT device. However, in some forms of the presenttechnology, some methodologies may be performed by a remotely locateddevice. For example, the remotely located device may determine controlsettings for a ventilator or detect respiratory related events byanalysis of stored data such as from any of the sensors describedherein.

5.4.2.4 Clock

The RPT device may include a clock that is connected to the centralcontroller.

5.4.2.5 Therapy Device Controller

In one form of the present technology, the blower may be under thecontrol of a therapy device controller. The therapy device controllermay be a therapy control module that forms part of the algorithmsexecuted by the central controller.

In one form of the present technology, therapy device controller is adedicated motor control integrated circuit. For example, in one form aMC33035 brushless DC motor controller, manufactured by ONSEMI is used.

5.4.2.6 Protection Circuits

The one or more protection circuits in accordance with the presenttechnology may comprise an electrical protection circuit, a temperatureand/or pressure safety circuit.

5.4.2.7 Memory

In accordance with one form of the present technology the RPT deviceincludes memory, e.g., non-volatile memory. In some forms, memory mayinclude battery powered static RAM. In some forms, memory may includevolatile RAM.

Memory may be located on the PCBA. Memory may be in the form of EEPROM,or NAND flash.

Additionally or alternatively, RPT device includes a removable form ofmemory, for example a memory card made in accordance with the SecureDigital (SD) standard.

In one form of the present technology, the memory acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms.

5.4.2.8 Data Communication Systems

In one form of the present technology, a data communication interface isprovided, and is connected to the central controller. Data communicationinterface may be connectable to a remote external communication networkand/or a local external communication network. The remote externalcommunication network may be connectable to a remote external device.The local external communication network may be connectable to a localexternal device.

In one form, data communication interface is part of the centralcontroller. In another form, data communication interface is separatefrom the central controller, and may comprise an integrated circuit or aprocessor.

In one form, remote external communication network is the Internet. Thedata communication interface may use wired communication (e.g. viaEthernet, or optical fibre) or a wireless protocol (e.g. CDMA, GSM, LTE)to connect to the Internet.

In one form, local external communication network utilises one or morecommunication standards, such as Bluetooth, or a consumer infraredprotocol.

In one form, remote external device is one or more computers, forexample a cluster of networked computers. In one form, remote externaldevice may be virtual computers, rather than physical computers. Ineither case, such a remote external device may be accessible to anappropriately authorised person such as a clinician.

The local external device may be a personal computer, mobile phone,tablet or remote control.

5.4.2.9 Output Devices Including Optional Display, Alarms

An output device in accordance with the present technology may take theform of one or more of a visual, audio and haptic unit. A visual displaymay be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED)display.

5.4.2.9.1 Display Driver

A display driver receives as an input the characters, symbols, or imagesintended for display on the display, and converts them to commands thatcause the display to display those characters, symbols, or images.

5.4.2.9.2 Display

A display is configured to visually display characters, symbols, orimages in response to commands received from the display driver. Forexample, the display may be an eight-segment display, in which case thedisplay driver converts each character or symbol, such as the figure“0”, to eight logical signals indicating whether the eight respectivesegments are to be activated to display a particular character orsymbol.

5.4.3 RPT Device Accessories 5.4.3.1 External Battery

An external battery 9000 according to some forms of the presenttechnology is shown in FIGS. 4W1 and 4W2.

The external battery 9000 may be engageable with the RPT device 8000,for example as shown in FIGS. 4X1 to 4Y2. The external battery 9000 maycomprise a guiding member to facilitate alignment and connection withthe RPT device 8000 (as well as disconnection). In one form, theexternal battery 9000 may comprise one or more guide slots 9050, eachconfigured to receive a respective guide rail 8019 of the RPT device8000. The guide slot 9050 may further comprise a latch 9060 releasableby a latch button 9065. The latch 9060 may be configured to engage withthe recessed slot 8110 along the guide rail 8019 of the RPT device 8000to retain the RPT device 8000 with respect to the external battery 9000.

In some forms, the external battery 9000 may comprise a facia 9100 asshown in FIG. 4W1, the facia being engageable with an end of the RPTdevice 8000 as shown in FIG. 4Y1.

The facia 9100 may comprise at least one of an air inlet 9018 and an airoutlet 9020, for extending an air path of the RPT device 8000. The airinlet 9018 and/or the air outlet 9020 may be configured substantiallyidentically to the housing inlet 8018 and the housing outlet 8020respectively. Thus, a user may be able to use the same air conduit 4170regardless of whether the air conduit is being connected to the RPTdevice 8000 or to the external battery 9000.

In some cases, the battery 9000 may comprise a muffler such that thenoise output of the RPT device 8000 is reduced. For example, the mufflermay reduce a noise output from the housing outlet 8020 so that it isreduced at the air outlet 9020. Additionally, or alternatively, themuffler may reduce a noise output from the housing inlet 8018 so thatnoise from (e.g., measured at) the air inlet 9018 is lower than noisefrom (e.g., measured at) the housing inlet 8018.

In some examples, the battery facia 9100 may comprise a muffling chamberlocated between the housing outlet 8020 and the air outlet 9020. Inother examples, the battery facia 9100 may comprise a muffling chamberlocated between the housing inlet 8018 and the air inlet 9018. To thisend, the air outlet 9020 may be displaced from the housing outlet 8020,e.g., by approximately 30 mm. It will be however understood that othermeans of noise reduction may be possible between the housing outlet 8020and the air outlet 9020, and the housing inlet 8018 and the air inlet9018.

The external battery may comprise one or more battery cells (e.g.,Lithium-Ion cells, or Nickel-metal hydride cells) configured to storeelectrical energy, and a printed circuit board assembly (PCBA) connectedthereto.

The PCBA may comprise components and/or circuitry for controlling one ormore operations of the battery, such as power management, communicationwith the RPT device 8000 and/or voltage conversion.

The external battery may generate heat, such as from the PCBA and/or thebattery cells. Thus, it may be preferred to manage heat output from theexternal battery such that the PCBA and the battery cells operate withintheir preferred environmental conditions.

In one aspect of the present technology, the external battery 9000 maybe configured to be thermally coupled to the RPT device 8000. The RPTdevice 8000 comprises an air path within, wherein ambient air is drawnin through its inlet (e.g., housing inlet 8018) and delivered throughits outlet (e.g., housing outlet 8020).

Thus, the air flow of the RPT device 8000 may be used to cool one ormore components of the external battery 9000. That is, heat conductedfrom the external battery 9000 to the RPT device 8000 may be removedfrom the RPT device 8000 by convection.

The external battery 9000 may be configured such that its generated heatis more efficiently delivered to the RPT device 8000 for convectivecooling. For example, higher heat generating components of the externalbattery 9000 may be located proximal to the RPT device 8000 whenassembled. In another example, the external battery 9000 may comprise athermally conductive element configured to deliver heat towards the RPTdevice 8000 when assembled.

In one form, such as shown in FIG. 4Y1 wherein the external battery 9000is configured to couple below the RPT device, a higher heat generatingcomponent of the external battery 9000 may be located towards the top ofthe external battery to improve heat transfer. In another form, theexternal battery 9000 may comprise a heat pipe to improve thermalconduction from a higher heat generating component to an exterior of theexternal battery 9000, such that heat transfer to the RPT device 8000may be improved when they are coupled together.

Furthermore, the external battery 9000 may be configured to improvethermal conductivity between it and the RPT device 8000. For example,the external battery 9000 may comprise one or more conductive portions(e.g., surfaces) configured to thermally couple with the RPT device 8000for heat transfer when engaged thereto.

5.4.4 RPT Device Algorithms 5.4.4.1 Pre-Processing Module

As shown in FIG. 4V, a pre-processing module 4310 in accordance with oneform of the present technology receives as an input a signal from atransducer, for example a flow rate sensor or pressure sensor, andperforms one or more process steps to calculate one or more outputvalues that will be used as an input to another module, for example atherapy engine module 4320.

In one form of the present technology, the output values include theinterface or mask pressure Pm, the respiratory flow rate Qr, and theleak flow rate Ql.

In various forms of the present technology, the pre-processing module4310 comprises one or more of the following algorithms: pressurecompensation 4312, vent flow rate estimation 4314, leak flow rateestimation 4316, and respiratory flow rate estimation 4318.

5.4.4.2 Therapy Control Module

Therapy control module 4330 in accordance with one aspect of the presenttechnology receives as inputs the therapy parameters from the therapyparameter determination algorithm of the therapy engine module 4320, andcontrols the pressure generator to deliver a flow of air in accordancewith the therapy parameters.

In one form of the present technology, the therapy parameter is atreatment pressure Pt, and the therapy control module 4330 controls thepressure generator to deliver a flow of air whose mask pressure Pm atthe patient interface 3000 is equal to the treatment pressure Pt.

5.5 HUMIDIFIER 5.5.1 Humidifier Overview

The RPT device 8000 may be configured to be connected, in use, to ahumidifier for changing the absolute humidity of air or gas for deliveryto a patient relative to ambient air. In one form the humidifier is inthe form of a moisture exchanger positioned in the path of air circuit4170. Alternatively, RPT device 8000 may deliver air to a patientwithout humidification.

In one form of the present technology there is provided a humidifier5000 (e.g. as shown in FIG. 5A) to change the absolute humidity of airor gas for delivery to a patient relative to ambient air. Typically, thehumidifier 5000 is used to increase the absolute humidity and increasethe temperature of the flow of air (relative to ambient air) beforedelivery to the patient's airways.

The humidifier 5000 may comprise a humidifier reservoir 5110, ahumidifier inlet 5002 to receive a flow of air, and a humidifier outlet5004 to deliver a humidified flow of air. In some forms, as shown inFIG. 5A and FIG. 5B, an inlet and an outlet of the humidifier reservoir5110 may be the humidifier inlet 5002 and the humidifier outlet 5004respectively. The humidifier 5000 may further comprise a humidifier base5006, which may be adapted to receive the humidifier reservoir 5110 andcomprise a heating element 5240.

5.5.2 Humidifier Mechanical Components 5.5.2.1 Water Reservoir

According to one arrangement, the humidifier 5000 may comprise a waterreservoir 5110 configured to hold, or retain, a volume of liquid (e.g.water) to be evaporated for humidification of the flow of air. The waterreservoir 5110 may be configured to hold a predetermined maximum volumeof water in order to provide adequate humidification for at least theduration of a respiratory therapy session, such as one evening of sleep.Typically, the reservoir 5110 is configured to hold several hundredmillilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400ml. In other forms, the humidifier 5000 may be configured to receive asupply of water from an external water source such as a building's watersupply system.

According to one aspect, the water reservoir 5110 is configured to addhumidity to a flow of air from the RPT device 4000 as the flow of airtravels therethrough. In one form, the water reservoir 5110 may beconfigured to encourage the flow of air to travel in a tortuous paththrough the reservoir 5110 while in contact with the volume of watertherein.

According to one form, the reservoir 5110 may be removable from thehumidifier 5000, for example in a lateral direction as shown in FIG. 5Aand FIG. 5B.

The reservoir 5110 may also be configured to discourage egress of liquidtherefrom, such as when the reservoir 5110 is displaced and/or rotatedfrom its normal, working orientation, such as through any aperturesand/or in between its sub-components. As the flow of air to behumidified by the humidifier 5000 is typically pressurised, thereservoir 5110 may also be configured to prevent losses in pneumaticpressure through leak and/or flow impedance.

5.5.2.2 Conductive Portion

According to one arrangement, the reservoir 5110 comprises a conductiveportion 5120 configured to allow efficient transfer of heat from theheating element 5240 to the volume of liquid in the reservoir 5110. Inone form, the conductive portion 5120 may be arranged as a plate,although other shapes may also be suitable. All or a part of theconductive portion 5120 may be made of a thermally conductive materialsuch as aluminium (e.g. approximately 2 mm thick, such as 1 mm, 1.5 mm,2.5 mm or 3 mm), another heat conducting metal or some plastics. In somecases, suitable heat conductivity may be achieved with less conductivematerials of suitable geometry.

5.5.2.3 Humidifier Reservoir Dock

In one form, the humidifier 5000 may comprise a humidifier reservoirdock 5130 (as shown in FIG. 5B) configured to receive the humidifierreservoir 5110. In some arrangements, the humidifier reservoir dock 5130may comprise a locking feature such as a locking lever 5135 configuredto retain the reservoir 5110 in the humidifier reservoir dock 5130.

5.5.2.4 Water Level Indicator

The humidifier reservoir 5110 may comprise a water level indicator 5150as shown in FIG. 5A-5B. In some forms, the water level indicator 5150may provide one or more indications to a user such as the patient 1000or a care giver regarding a quantity of the volume of water in thehumidifier reservoir 5110. The one or more indications provided by thewater level indicator 5150 may include an indication of a maximum,predetermined volume of water, any portions thereof, such as 25%, 50% or75% or volumes such as 200 ml, 300 ml or 400 ml.

5.5.3 Humidifier Electrical & Thermal Components

The humidifier 5000 may comprise a number of electrical and/or thermalcomponents such as those listed below.

5.5.3.1 Humidifier Transducer(s)

The humidifier 5000 may comprise one or more humidifier transducers(sensors) 5210 instead of, or in addition to, transducers describedabove. Humidifier transducers 5210 may include one or more of an airpressure sensor 5212, an air flow rate transducer 5214, a temperaturesensor 5216, or a humidity sensor 5218 as shown in FIG. 5C. A humidifiertransducer 5210 may produce one or more output signals which may becommunicated to a controller such as the central controller and/or thehumidifier controller 5250. In some forms, a humidifier transducer maybe located externally to the humidifier 5000 (such as in the air circuit4170) while communicating the output signal to the controller.

5.5.3.1.1 Pressure Transducer

One or more pressure transducers 5212 may be provided to the humidifier5000 in addition to, or instead of, a pressure sensor provided in theRPT device.

5.5.3.1.2 Flow Rate Transducer

One or more flow rate transducers 5214 may be provided to the humidifier5000 in addition to, or instead of, a flow rate sensor provided in theRPT device.

5.5.3.1.3 Temperature Transducer

The humidifier 5000 may comprise one or more temperature transducers5216. The one or more temperature transducers 5216 may be configured tomeasure one or more temperatures such as of the heating element 5240and/or of the flow of air downstream of the humidifier outlet 5004. Insome forms, the humidifier 5000 may further comprise a temperaturesensor 5216 to detect the temperature of the ambient air.

5.5.3.1.4 Humidity Transducer

In one form, the humidifier 5000 may comprise one or more humiditysensors 5218 to detect a humidity of a gas, such as the ambient air. Thehumidity sensor 5218 may be placed towards the humidifier outlet 5004 insome forms to measure a humidity of the gas delivered from thehumidifier 5000. The humidity sensor may be an absolute humidity sensoror a relative humidity sensor.

5.5.3.2 Heating Element

A heating element 5240 may be provided to the humidifier 5000 in somecases to provide a heat input to one or more of the volume of water inthe humidifier reservoir 5110 and/or to the flow of air. The heatingelement 5240 may comprise a heat generating component such as anelectrically resistive heating track. One suitable example of a heatingelement 5240 is a layered heating element such as one described in thePCT Patent Application Publication No. WO 2012/171072, which isincorporated herewith by reference in its entirety.

In some forms, the heating element 5240 may be provided in thehumidifier base 5006 where heat may be provided to the humidifierreservoir 5110 primarily by conduction as shown in FIG. 5B.

5.5.3.3 Humidifier Controller

According to one arrangement of the present technology, a humidifier5000 may comprise a humidifier controller 5250 as shown in FIG. 5C. Inone form, the humidifier controller 5250 may be a part of the centralcontroller 4230. In another form, the humidifier controller 5250 may bea separate controller, which may be in communication with the centralcontroller.

In one form, the humidifier controller 5250 may receive as inputsmeasures of characteristics (such as temperature, humidity, pressureand/or flow rate), for example of the flow of air, the water in thereservoir 5110 and/or the humidifier 5000. The humidifier controller5250 may also be configured to execute or implement humidifieralgorithms and/or deliver one or more output signals.

As shown in FIG. 5C, the humidifier controller 5250 may comprise one ormore controllers, such as a central humidifier controller 5251, a heatedair circuit controller 5254 configured to control the temperature of aheated air circuit 4170 and/or a heating element controller 5252configured to control the temperature of a heating element 5240.

5.6 BREATHING WAVEFORMS

FIG. 6 shows a model typical breath waveform of a person while sleeping.The horizontal axis is time, and the vertical axis is respiratory flowrate. While the parameter values may vary, a typical breath may have thefollowing approximate values: tidal volume, Vt, 0.5L, inhalation time,Ti, 1.6 s, peak inspiratory flow rate, Qpeak, 0.4 L/s, exhalation time,Te, 2.4 s, peak expiratory flow rate, Qpeak, −0.5 L/s. The totalduration of the breath, Ttot, is about 4 s. The person typicallybreathes at a rate of about 15 breaths per minute (BPM), withVentilation, Vent, about 7.5 L/minute. A typical duty cycle, the ratioof Ti to Ttot is about 40%.

5.7 GLOSSARY

For the purposes of the present technology disclosure, in certain formsof the present technology, one or more of the following definitions mayapply. In other forms of the present technology, alternative definitionsmay apply.

5.7.1 General

Air: In certain forms of the present technology, air may be taken tomean atmospheric air, and in other forms of the present technology airmay be taken to mean some other combination of breathable gases, e.g.atmospheric air enriched with oxygen.

Ambient: In certain forms of the present technology, the term ambientwill be taken to mean (i) external of the treatment system or patient,and (ii) immediately surrounding the treatment system or patient.

For example, ambient humidity with respect to a humidifier may be thehumidity of air immediately surrounding the humidifier, e.g. thehumidity in the room where a patient is sleeping. Such ambient humiditymay be different to the humidity outside the room where a patient issleeping.

In another example, ambient pressure may be the pressure immediatelysurrounding or external to the body.

In certain forms, ambient (e.g., acoustic) noise may be considered to bethe background noise level in the room where a patient is located, otherthan for example, noise generated by an RPT device or emanating from amask or patient interface. Ambient noise may be generated by sourcesoutside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in whichthe treatment pressure is automatically adjustable, e.g. from breath tobreath, between minimum and maximum limits, depending on the presence orabsence of indications of SDB events.

Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressuretherapy in which the treatment pressure is approximately constantthrough a respiratory cycle of a patient. In some forms, the pressure atthe entrance to the airways will be slightly higher during exhalation,and slightly lower during inhalation. In some forms, the pressure willvary between different respiratory cycles of the patient, for example,being increased in response to detection of indications of partial upperairway obstruction, and decreased in the absence of indications ofpartial upper airway obstruction.

Flow rate: The volume (or mass) of air delivered per unit time. Flowrate typically refers to an instantaneous quantity unless statedotherwise. In some cases, a reference to flow rate will be a referenceto a scalar quantity, namely a quantity having magnitude only. In othercases, a reference to flow rate will be a reference to a vectorquantity, namely a quantity having both magnitude and direction. Flowrate may be given the symbol Q. ‘Flow rate’ is sometimes shortened tosimply ‘flow’.

Patient: A person, whether or not they are suffering from a respiratorydisease.

Pressure: Force per unit area. Pressure may be measured in a range ofunits, including cmH₂O, g-f/cm², hectopascal. 1 cmH₂O is equal to 1g-f/cm² and is approximately 0.98 hectopascal. In this specification,unless otherwise stated, pressure is given in units of cmH₂O.

Respiratory Pressure Therapy (RPT): The application of a supply of airto an entrance to the airways at a treatment pressure that is typicallypositive with respect to atmosphere.

Seal: May be a noun form (“a seal”) which refers to a structure, or averb form (“to seal”) which refers to the effect. Two elements may beconstructed and/or arranged to ‘seal’ or to effect ‘sealing’therebetween without requiring a separate ‘seal’ element per se.

Sound Power: The energy per unit time carried by a sound wave. The soundpower is proportional to the square of sound pressure multiplied by thearea of the wavefront. Sound power is usually given in decibels SWL,that is, decibels relative to a reference power, normally taken as 10¹²watt.

Sound Pressure: The local deviation from ambient pressure at a giventime instant as a result of a sound wave travelling through a medium.Sound pressure is usually given in decibels SPL, that is, decibelsrelative to a reference pressure, normally taken as 20×10⁻⁶ Pascal (Pa),considered the threshold of human hearing.

5.7.2 Terms for RPT Devices

Leak: The word leak will be taken to be an unintended flow of air. Inone example, leak may occur as the result of an incomplete seal betweena mask and a patient's face. In another example leak may occur in aswivel elbow to the ambient.

Noise, conducted (acoustic): Conducted noise in the present documentrefers to noise which is carried to the patient by the pneumatic path,such as the air circuit and the patient interface as well as the airtherein. In one form, conducted noise may be quantified by measuringsound pressure levels at the end of an air circuit.

Noise, radiated (acoustic): Radiated noise in the present documentrefers to noise which is carried to the patient by the ambient air. Inone form, radiated noise may be quantified by measuring soundpower/pressure levels of the object in question according to ISO 3744.

Noise, vent (acoustic): Vent noise in the present document refers tonoise which is generated by the flow of air through any vents such asvent holes in the patient interface.

5.7.3 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, an exemplary form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240

Polycarbonate: a typically transparent thermoplastic polymer ofBisphenol-A Carbonate.

5.8 OTHER REMARKS

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct acomponent, obvious alternative materials with similar properties may beused as a substitute. Furthermore, unless specified to the contrary, anyand all components herein described are understood to be capable ofbeing manufactured and, as such, may be manufactured together orseparately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by referencein their entirety to disclose and describe the methods and/or materialswhich are the subject of those publications. The publications discussedherein are provided solely for their disclosure prior to the filing dateof the present application. Nothing herein is to be construed as anadmission that the present technology is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dates,which may need to be independently confirmed.

The terms “comprises” and “comprising” should be interpreted asreferring to elements, components, or steps in a non-exclusive manner,indicating that the referenced elements, components, or steps may bepresent, or utilized, or combined with other elements, components, orsteps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative examples and that other arrangements may be devisedwithout departing from the spirit and scope of the technology.

5.9 REFERENCE SIGNS LIST

Number Feature Item inlet tube array    52A inlet tube array    52Binlet tube array    52C patient 1000 bed partner 1100 patient interface3000 seal - forming structure 3100 plenum chamber 3200 stabilisingstructure 3300 vent 3400 connection port 3600 forehead support 3700 RPTdevice 4000 air circuit 4170 pre - processing module 4310 pressurecompensation algorithm 4312 vent flow rate estimation algorithm 4314leak flow rate estimation algorithm 4316 flow rate estimation algorithm4318 therapy engine module 4320 therapy control module 4330 humidifier5000 humidifier inlet 5002 humidifier outlet 5004 humidifier base 5006reservoir 5110 conductive portion 5120 humidifier reservoir dock 5130locking lever 5135 water level indicator 5150 humidifier transducer 5210pressure transducer 5212 flow rate transducer 5214 temperaturetransducer 5216 humidity sensor 5218 heating element 5240 humidifiercontroller 5250 central humidifier controller 5251 heating elementcontroller 5252 air circuit controller 5254 RPT device 8000 firstchamber 8001 second chamber 8002 power button 8003 button portion  8003A button portion   8003B bluetooth connection button 8004 opening  8004A button portion   8004B interior chamber portion 8006 interiorchamber portion 8007 housing 8010 connector anchors 8011 top housingportion 8012 base mold   8012A overmold   8012B bottom housing portion8014 base mold   8014A overmold   8014B slot   8015A slot   8015B firstend portion 8016 interior rib 8017 housing inlet 8018 rail 8019 housingoutlet 8020 cover plate 8021 second end portion 8022 opening 8023faceplate 8024 opening 8025 tube portion 8026 tube portion 8027 interiorwall 8028 end wall   8028A end wall   8028B blower 8030 housing 8031inlet 8032 impeller   8033A impeller   8033B impeller   8033C outlet8034 motor 8035 collar 8036 notch 8037 electrical connector portion 8038intermediate cover 8040 base mold   8040A overmold   8040B slot   8042Aslot   8042B main wall 8044 first plate assembly 8050 base plate 8051inlet tube array 8052 first end portion   8052A second end portion  8052B tube portion 8053 opening   8053A blower suspension 8054 firstend portion   8054A second end portion   8054B gusset portion   8054Cinlet tube 8055 outlet bellow 8056 end portion   8056A bellows portion  8056B projections   8056C pressure port 8058 sealing lip 8059 secondplate assembly 8060 base plate 8061 flow tube array 8062 opening 8063blower suspension 8064 outer portion   8064A inner portion   8064Bintermediate portion   8064C flow tube 8065 first end portion   8065Asecond end portion   8065B tongue 8066 sealing lip 8069 PCBA 8070 mainPCB 8072 secondary PCB 8074 electrical socket 8080 electrical connector8090 connector tab 8092 recessed slot 8110 external battery 9000 airinlet 9018 air outlet 9020 guide slot 9050 latch 9060 latch button 9065facia 9100

1. Apparatus for generating a supply of air at positive pressure for theamelioration or treatment of a respiratory disorder, the apparatuscomprising: a housing; a blower positioned in the housing, the blowerbeing structured and configured to produce a flow of air at positivepressure; a flexible connector electrically and physically connected tothe blower; and a blower rotation limitation structure configured toreduce rotation of the blower during use.
 2. Apparatus according toclaim 1, wherein the apparatus comprises a first blower suspensionstructured and configured to support a first end of the blower. 3.Apparatus according to claim 2, wherein the blower rotation limitationstructure comprises a first rotation limitation member provided on thefirst blower suspension, the first rotation limitation memberinteracting in use with a second rotation limitation member provided onthe blower to limit rotation of the blower.
 4. Apparatus according toclaim 3, wherein the second rotation limitation member comprises a notchon the blower and the first rotation limitation member comprises atongue provided to the first blower suspension, the notch and tonguebeing configured to engage with each other to limit rotation of theblower.
 5. Apparatus according to claim 4, wherein the blower comprisesa collar around a blower inlet and the notch is provided in the collar.6. Apparatus according to claim 4, wherein the first blower suspensioncomprises a circular aperture and the tongue protrudes radially inwardlyfrom an inner edge of the circular aperture.
 7. Apparatus according toclaim 1, wherein the blower rotation limitation structure is configuredsuch that the flexible connector is not under stress during operation ofthe apparatus.
 8. Apparatus according to claim 2, wherein the apparatuscomprises a second blower suspension structured and configured tosupport a second end of the blower, the second end being at an oppositeend of the blower to the first end.
 9. Apparatus according to claim 8,wherein the apparatus comprises: a first plate assembly, wherein thefirst plate assembly comprises the first blower suspension and the firstblower suspension supports the blower adjacent a blower outlet of theblower; and a second plate assembly, wherein the second plate assemblycomprises the second blower suspension and the second blower suspensionsupports the blower adjacent a blower inlet of the blower.
 10. Apparatusaccording to claim 9, wherein the apparatus comprises at least onechamber and the first plate assembly comprises a first base plate thatdefines at least in part a wall of the at least one chamber and thesecond plate assembly comprises a second base plate that defines atleast in part a wall of the at least one chamber.
 11. Apparatusaccording to claim 10, wherein the at least one chamber comprises an airflow path and the flexible connector passes through the at least onechamber while not being positioned directly in the air flow path. 12.Apparatus according to claim 10, wherein the apparatus further comprisesat least one inlet tube structured and configured to allow ambient airto enter a chamber, wherein the flexible connector is arranged to passaround a periphery of the at least one inlet tube.
 13. Apparatusaccording to claim 1, wherein the apparatus comprises one or moreconnector anchors for anchoring a longitudinal middle section of theflexible connector to another part of the apparatus.
 14. Apparatusaccording to claim 13, wherein the one or more connector anchorscomprises one or more posts.
 15. Apparatus according to claim 13,wherein the housing comprises the one or more connector anchors. 16.Apparatus according to claim 13, wherein the longitudinal middle sectionof the flexible connector comprises one or more holes and/or hooksconfigured to engage with the one or more connector anchors. 17.Apparatus according to claim 16, wherein the longitudinal middle sectionof the flexible connector comprises one or more tabs, wherein the one ormore holes and/or hooks are provided in the one or more tabs. 18.Apparatus according to claim 1, wherein the flexible connector comprisesat least one of: a flexible circuit board; flexible printed circuit; anda flexible flat cable.
 19. Apparatus for generating a supply of air atpositive pressure for the amelioration or treatment of a respiratorydisorder, the apparatus comprising: a housing; a blower positioned inthe housing, the blower being structured and configured to produce aflow of air at positive pressure; a first blower suspension structuredand configured to support a first end of the blower adjacent a bloweroutlet of the blower; a second blower suspension structured andconfigured to support a second end of the blower adjacent a blower inletof the blower, the second end being at an opposite end of the blower tothe first end; and a blower rotation limitation structure configured toreduce rotation of the blower during use.
 20. Apparatus according toclaim 19, wherein the apparatus comprises a first plate assembly and asecond plate assembly, wherein the first plate assembly comprises thefirst blower suspension and a first base plate and the second plateassembly comprises the second blower suspension and a second base plate.